GM food and feed: EU legislation and post-market monitoring S A N - - PowerPoint PPT Presentation

S A N D Y L A W R I E N O V E L F O O D S U N I T U K F O O D S T A N D A R D S A G E N C Y G M S A F O O D C O N F E R E N C E M A R C H 2 0 1 2

GM food and feed: EU legislation and post-market monitoring

contents

— what is the legislation on GM food and feed? — what does the legislation say about post-market

monitoring?

— how does it work in other areas of EU legislation? — what is the current thinking re PMM and the safety

• f GM food and feed?

Regulation (EC) 1829/2003

• n GM food and feed

“one-stop-shop” for approval (and re-authorisation) of GM crops / GMOs used for food and feed This regulation covers:

– Cultivation of the crop – Import of the GMO – Marketing of food and feed – Labelling of food and feed

Implementing acts cover:

– authorisation requests – low level presence [in feed] etc

Criteria for authorisation

GM food and feed must not:

— Present a risk — Mislead — Be nutritionally disadvantageous*

Validated detection methods must be available

* compared with the food/feed they might replace

Directive 2001/18/EC

• n deliberate release of GMOs

— provides the definition of “GM” — sets out criteria for environmental aspects — framework for regulating crop trials (at national

level) and for non-food crops

Evaluation of legislation

— Legislation is kept under review — Two evaluation reports were published by

Commission in 2011

¡ 1829/2003: GM food and feed ¡ 2001/18: deliberate release

— No legislative changes are being proposed — Commission seeks to improve implementation of

existing legislation

POST MARKET MONITORING

Legislative requirements for GM food/feed How does it work in other areas? (examples) Current thinking

GM food and feed

Regulation 1829/2003 refers to PMM in relation to:

¡ the application for authorisation ¡ the EFSA opinion ¡ the authorisation decision

Requirements for GM food & feed

Regulation 1829/2003, recital 35:

“it is necessary to introduce, where appropriate and on the basis

• f the conclusions of the risk assessment, post-market

monitoring requirements for the use of GM foods … and GM feed …”

Note: in the case of GMOs, monitoring concerning environmental effects is compulsory

Applications for GM food and feed

Regulation 1829/2003, article 5(3)

“The application shall be accompanied by the following: … (k) where appropriate, a proposal for post-market monitoring regarding the use of the food for human consumption”

EFSA opinions

Regulation 1829/2003, article 6(5):

“In the event of an opinion in favour of authorising the food, the

• pinion shall also include

… (e) where applicable … post-market monitoring requirements based on the outcome of the risk assessment …”

Obligations on authorisation-holders

Regulation 1829/2003, article 9(1):

“… Where post-market monitoring … has been imposed on the authorisation-holder, the authorisation-holder shall ensure that it is carried out and shall submit reports to the Commission in accordance with the terms of the authorisation.”

Examples of PMM questions

• How much is produced? In what foods is it present? At

what levels? Usage

• Who are the consumers? How much are they eating?

Exposure

• Is it having effects (beneficial or adverse) on consumers?

Effects

What is the value of monitoring?

Results of post-market monitoring can help refine and/or

Risk assessment Risk management

How does it work in other areas?

(a) pesticides – (b) food additives – (c) novel foods

(a) pesticide residues in food

Regulation 396/2005:

÷ each member state must have a national monitoring programme ÷ member states must also take part in a EU harmonised

programme for specified pesticides in particular foods

Purpose is primarily to check residues against mandatory

• limits. In some cases, illegal residues may raise health

concerns

(b) food additives

Regulation 1333/2008

÷ producers or users may be requested to produce data on the actual

use of a food additive (Article 26)

÷ member states need to maintain systems to monitor the

consumption and use of food additives on a risk-based approach and report their findings (Article 27)

Purpose is primarily to check exposure against Acceptable Daily Intakes set of individual additives

(c) novel foods

post-market monitoring is a possibility for any novel food, as a condition of authorisation two examples to date:

¡ phytosterols ¡ lycopene

Novel food: phytosterols

authorised as an ingredient in yellow fat spreads

— uncertainty about levels of consumption of products

that contain the new ingredient

— the applicant was required to provide a report after

18 months, for review by SCF

¡ Results were reassuring; additional uses of phytosterols have

been approved

¡ surveys of usage have been conducted by national authorities

in IE, UK and, most recently, BE

Novel food: lycopene

— applications from different companies for use of new

lycopene preparations in foods

(already approved as a food colour)

— EFSA advised that average users will stay below the

ADI but some users could exceed the ADI

— Commission and MS agreed that

÷ authorisation should proceed, but ÷ monitoring should be carried out

lycopene (continued)

Each applicant should provide monitoring reports for July 2009 to June 2012:

÷ quantities supplied ÷ product launches (+ levels of use + portion sizes) ÷ info on intake of Lycopene used as a food colour ÷ new scientific information for a reconsideration of safety ÷ updated intake assessments based on the above

Examples of PMM questions

• How much is produced? In what foods is it present? At

what levels? Usage

• Who are the consumers? How much are they eating?

Exposure

• Is it having effects (beneficial or adverse) on consumers?

Effects

GM food and feed: current discussions

Draft Commission Regulation on requirements for applicants

÷ based on latest EFSA guidance on GM food/feed from GM plants ÷ includes an article that would clarify how applicants should

address PMM

Regulation 1829/2003, article 5(3)

“The application shall be accompanied by the following: … (k) where appropriate, a proposal for post-market monitoring regarding the use of the food for human consumption”

PMM: when?

Commission’s draft proposal:

“The applicant shall submit a proposal … when it is appropriate to confirm:

(a)

that the specific recommendations of uses are followed by the consumer / animal owner;

(b)

the predicted consumption of the GM food or feed; or

(c)

the relevance and intensity of effects and side-effects detected during the pre-market risk assessment which can only be further characterised by PMM.”

PMM: how?

Commission’s draft proposal (not verbatim):

÷

PMM information shall identify whether any (adverse) effect on health may be related to consumption of GM food/feed

÷

information will be collected from relevant stakeholders, including consumers, and may involve particular foods or age groups

÷

the proposed approach will be justified and thoroughly described

Putting the cart before the horse?

thank you